Cortical Plasticity Assessment in Athletes With a History of Concussion

NCT ID: NCT01112761

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this research is to determine whether athletes with concussion have changes in cortical excitability.

Single and paired transcranial magnetic stimulation (TMS) can be used as reliable neurophysiological marker of motor cortex reorganization in athletes with concussions.

This study also aims to determine whether modulation of cortical activity by a powerful technique of noninvasive brain stimulation (tDCS) results in a different cortical response as compared with sham tDCS.

Detailed Description

This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret).

Conditions

Concussion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Healthy Subjects

Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.

Athletes with history of concussion

Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.

Interventions

Transcranial direct current stimulation

Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Student-athletes at risk for traumatic brain injury (collegiate football, ice hockey)
• Age between 18 and 30 yr.
• Concussion as defined by the American Academy of Neurology: trauma-induced alteration in mental status that may or may not involve loss of consciousness (confusion and amnesia are the hallmarks of concussion)
• Concussion that occurred > 6 months
• All head injuries classified as minor with a Glasgow Coma Scale of 13 to 15 at the time of the trauma
• Participants are cleared for full sport participation based upon neurological and neuropsychological (NS) assessments Classified as symptomatic based on Post-concussion Symptom List

Exclusion Criteria

• Previous significant neurological history
• Use of tricyclic anti-depressants such as amitriptyline, nortriptyline and imipramine within the past six months.
• Use of anticonvulsants such as carbamazepine, phenytoin, valproic acid and gabapentin within the past six months
• History of seizures, depression or PTSD
• Presence of post-concussion symptoms such as complaints of loss of concentration, dizziness, fatigue, headache, irritability, visual disturbances, and light sensitivity.
• Contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants
• history of seizures
• unexplained loss of consciousness
• metal in the head
• frequent or severe headaches or neck pain
• implanted brain medical devices.
• Contraindications to tDCS:
• metal in the head
• implanted brain medical devices

For the control group (subjects with no concussion) we will select subjects according to the previously stated list of exclusions as well as the following criteria: Subjects who are athletes (similar to the concussed group) with the same age range and also similar level of education; however these subjects will have no prior history of concussion or neurological insult as self reported. They should also have no contraindications to TMS or tDCS.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, PhD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010P000191

Identifier Type: -

Identifier Source: org_study_id